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Escitalopram for Anxiety (PrEcISE Trial)
PrEcISE Trial Summary
This trial will test whether a person's metabolism affects how they respond to the drug escitalopram. 132 people will be given the drug and monitored for 12 weeks.
PrEcISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPrEcISE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 115 Patients • NCT01902004PrEcISE Trial Design
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Who is running the clinical trial?
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- You have a mood disorder like depression, eating disorder, bipolar disorder, or psychotic disorder, except for specific types of depression and anxiety disorders.You have experienced allergies, intolerance, non-response, or extreme sensitivity to escitalopram.I am between 12 and 17 years old.Your overall level of symptoms is rated as moderate to severe by the doctor during two visits.I cannot swallow pills.You have had problems with alcohol or drugs in the past 6 months, but smoking is allowed.I have taken a pregnancy test and it was negative.I have had a major illness or head injury that caused me to lose consciousness for 5 minutes or more.You have experienced a significant amount of traumatic events in the past.I started or plan to start/change psychotherapy around the time of my first visit.I am between 12 and 17 years old.You have been diagnosed with an intellectual disability at any point in your life.I have been diagnosed with anxiety disorder.I have taken SSRIs recently or am on medication affecting my mood.I live more than 90 minutes away from the treatment center or cannot attend follow-up visits.You have been diagnosed with generalized, social, and/or separation anxiety disorder according to specific criteria.My drug test at the first visit was negative.I am using or willing to use an approved method of birth control during the study.You have a PARS score ≥15 at Visit 1 and Visit 2.My physical exam and heart test results are normal.You have a CGI-S score ≥4 at Visits 1 & 2.I haven't started new psychotherapy in the last 8 weeks and my current therapy has been stable for 2 months.I haven't started new psychotherapy in the last 8 weeks and my current therapy has been stable for 2 months.
- Group 1: Standard dosing
- Group 2: Pharmacogenetically-guided escitalopram dosing
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any unfilled positions within this investigation for participants?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was initially advertised on March 8th 2021, is currently enrolling participants. 132 individuals from 1 clinical site are being sought for this research program."
To what extent could Escitalopram be detrimental to individuals?
"Based on the Phase 4 status of Escitalopram, our team at Power assigned a score of 3 to its safety rating. This drug has already been approved for patient use."
What is the upper limit of individuals participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov informs that recruitment for this medical experiment is ongoing, commencing on the 8th of March 2021 and last updated on the 14th February 2022. In total, 132 individuals are required to participate at a single site."
What qualifications do potential participants need to meet in order to be eligible for this experiment?
"This clinical trial calls for 132 participants, aged between 12 and 17 years old and suffering from an anxiety disorder."
Are there any prior research studies that have explored the effects of Escitalopram?
"Presently, 23 different clinical trials are researching escitalopram with 5 of those in the final stages. Most of these tests take place in Cincinnati, Ohio though there are 45 distinct sites running this investigation."
Does this trial encompass participants aged 85 and over?
"This study is open to adolescents aged 12-17. Clinicialtrials.gov has 148 trials recruiting for individuals under 18 and 453 studies looking for participants over 65 years old."
Who else is applying?
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